Frank J W, Schabas R, Arshinoff R, Brant R
Department of Preventive Medicine and Biostatistics, University of Toronto.
CMAJ. 1989 Dec 15;141(12):1241-6.
A pilot study was undertaken to assess the validity of two new tests for predicting the immune response of Toronto schoolchildren with no acceptable evidence of prior administration of diphtheria or tetanus toxoid to a routine booster injection of diphtheria and tetanus (DT) toxoid. The tests, an inexpensive enzyme-linked immunosorbent assay (ELISA) fingerprick test for tetanus antibodies and a modification of the Schick skin test for susceptibility to diphtheria, were administered before the booster injection. One week later the ELISA test was repeated and the result of the modified Schick test read. On both occasions a diphtheria microneutralization assay was done for "gold standard" evidence of prior exposure to diphtheria toxoid or toxin. The results were used to determine the sensitivity and specificity of a single prebooster tetanus ELISA test or a modified Schick test for predicting which children with no records could be safely protected with only one DT booster dose instead of the primary series of three or four doses usually given to such children. Only 6 of the 34 subjects (18%) were totally without prior exposure to tetanus toxoid. Two of the six (6% of 33 subjects) appeared to mount a primary immune response to diphtheria toxoid as well. An initial ELISA titre of 0.01 IU/ml or lower correctly identified all six children needing a full series of tetanus toxoid (sensitivity for a primary immune response 100%) and falsely identified only 3 of 28 immune children as needing the series (specificity for immunity 89.3%). The modified Schick test appeared to have even greater accuracy for identifying children needing a full series of diphtheria toxoid. However, its use, entailing the costs of an extra nurse visit, would have prevented only seven more children from receiving an unnecessary full series of diphtheria toxoid than use of the baseline tetanus ELISA test alone.
开展了一项初步研究,以评估两种新测试的有效性,这两种测试用于预测多伦多学童的免疫反应,这些学童没有可接受的证据表明之前接种过白喉或破伤风类毒素,此次要接受白喉和破伤风(DT)类毒素的常规加强注射。在加强注射前进行了这两种测试,一种是用于检测破伤风抗体的廉价酶联免疫吸附测定(ELISA)手指针刺试验,另一种是用于检测对白喉易感性的改良锡克皮肤试验。一周后重复进行ELISA试验,并读取改良锡克试验的结果。在这两个时间点都进行了白喉微量中和试验,以获取之前接触白喉类毒素或毒素的“金标准”证据。结果用于确定单次加强注射前破伤风ELISA试验或改良锡克试验的敏感性和特异性,以预测哪些没有记录的儿童仅通过一剂DT加强注射就能得到安全保护,而无需像通常这类儿童那样接种三剂或四剂的基础系列疫苗。34名受试者中只有6名(18%)之前完全没有接触过破伤风类毒素。这6名中的2名(占33名受试者的6%)似乎对白喉类毒素也产生了初次免疫反应。初始ELISA滴度为0.01 IU/ml或更低能正确识别出所有6名需要全程接种破伤风类毒素的儿童(对初次免疫反应的敏感性为100%),并且仅将28名免疫儿童中的3名错误识别为需要全程接种(对免疫的特异性为89.3%)。改良锡克试验在识别需要全程接种白喉类毒素的儿童方面似乎具有更高的准确性。然而,使用该试验需要额外安排护士上门,与仅使用基线破伤风ELISA试验相比,只能多防止7名儿童接受不必要的全程白喉类毒素接种。